Objective:

To evaluate the efficacy and safety of oral gepotidacin for the treatment of uncomplicated urogenital gonorrhea.

Approach:

• Trial Design: A phase 3, randomized, open-label, sponsor-blinded, multicenter trial (EAGLE-1) was conducted across 49 sites in six countries.
• Participants: 628 participants aged 12 years or older were randomized into two treatment groups (314 each).
• Treatment Comparison: Gepotidacin (3,000 mg orally, two doses) was compared to ceftriaxone (500 mg IM) plus azithromycin (1 g orally).
• Primary Endpoint: Microbiological success was defined as culture-confirmed eradication of Neisseria gonorrhoeae at the test-of-cure visit (days 4 to 8).

Key Findings:

• Gepotidacin achieved 92.6% microbiological success compared to 91.2% for ceftriaxone plus azithromycin.
• The adjusted treatment difference was -0.1%, meeting the noninferiority margin of -10%.
• 100% microbiological success was reported for rectal gonorrhea with gepotidacin, while 80% success was observed with the comparator.
• For pharyngeal infections, success rates were 78% for gepotidacin and 94% for the comparator.
• Adverse events occurred in 74% of gepotidacin recipients, primarily mild to moderate gastrointestinal issues.

Interpretation:

Limitations:

• The trial was limited to participants with ceftriaxone-susceptible N gonorrhoeae isolates.

Conclusion:

Sources:

• The Lancet